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PROCTOFOAM HC RECTAL FOAM

Active substance(s): HYDROCORTISONE ACETATE / PRAMOCAINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Proctofoam HC Rectal Foam

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone acetate
Pramocaine hydrochloride

3

1.0% w/w
1.0% w/w

PHARMACEUTICAL FORM
Rectal foam

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the short term (not more than 5 - 7 days) relief of the symptoms of itching,
irritation, discomfort or pain associated with local, non infective anal or
perianal conditions.

4.2

Posology and method of administration
One applicator full per rectum two or three times daily and after each bowel
evacuation (up to a maximum of four times daily). For perianal
administration, apply a small quantity on two fingers.
Not recommended for use in children.

4.3

Contraindications
Hypersensitivity to pramocaine hydrochloride or to any component of the
preparation.
Bacterial, viral or fungal infection

4.4

Special warnings and precautions for use
Not for prolonged use. Contact sensitisation to local anaesthetics is common
following prolonged application.
Seek medical advice if symptoms worsen, or do not improve within 7 days or
if bleeding occurs.
Shake vigorously before use, use at room temperature, keep out of the reach of
children. For external use only.
Rectal examination must be performed to exclude serious pathology before
initiating treatment with Proctofoam
Patients and/or carers should be warned that potentially severe psychiatric
adverse reactions may occur with systemic steroids (see section 4.8).
Symptoms typically emerge within a few days or weeks of starting the
treatment. Risks may be higher with high doses/systemic exposure (see also
section 4.5 pharmacokinetic interactions that can increase the risk of side
effects), although dose levels do not allow prediction of the onset, type,
severity or duration of reactions. Most reactions recover after either dose
reduction or withdrawal, although specific treatment may be necessary.
Patients/carers should be encouraged to seek medical advice if worrying
psychological symptoms develop, especially if depressed mood or suicidal
ideation is suspected. Patients/carers should also be alert to possible
psychiatric disturbances that may occur either during or immediately after
dose tapering/withdrawal of systemic steroids, although such reactions have
been reported infrequently.
Particular care is required when considering the use of systemic
corticosteroids in patients with existing or previous history of severe affective
disorders in themselves or in their first degree relatives. These would include
depressive or manic-depressive illness and previous steroid psychosis.

4.5

Interaction with other medicinal products and other forms of interaction
None known.

4.6

Pregnancy and lactation
Safety for use in pregnancy and lactation has not been established.
There is inadequate evidence of safety in human pregnancy. Topical
administration of corticosteroids to pregnant animals can cause abnormalities
to foetal development including cleft palate and intrauterine growth
retardation. There may be a very small risk of such effects in the human
foetus. No data is available on the use of topical corticosteroids and local
anaesthetic agents in nursing mothers. However, the product has been used by
nursing mothers for many years without apparent ill consequence.

4.7

Effects on ability to drive and use machines
None known.

4.8

Undesirable effects
Although uncommon at this dosage; local burning, irritation, allergic dermatitis,
secondary infection and skin atrophy may occur. Systemic absorption of topical
corticosteroids has produced reversible suppression of the hypothalamic - pituitary adrenal axis and manifestations of Cushing's syndrome.
A wide range of psychiatric reactions including affective disorders (such as irritable,
euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions
(including mania, delusions, hallucinations, and aggravation of schizophrenia),
behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive
dysfunction including confusion and amnesia have been reported. Reactions are
common and may occur in both adults and children. In adults, the frequency of severe
reactions has been estimated to be 5-6%. Psychological effects have been reported on
withdrawal of corticosteroids; the frequency is unknown.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

Although uncommon at this dosage; local burning, irritation, allergic dermatitis, secondary
infection and skin atrophy may occur. Systemic absorption of topical corticosteroids has
produced reversible suppression of the hypothalamic - pituitary - adrenal axis and
manifestations of Cushing's syndrome.
A wide range of psychiatric reactions including affective disorders (such as irritable,
euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions
(including mania, delusions, hallucinations, and aggravation of schizophrenia),
behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive
dysfunction including confusion and amnesia have been reported. Reactions are
common and may occur in both adults and children. In adults, the frequency of severe
reactions has been estimated to be 5-6%. Psychological effects have been reported on
withdrawal of corticosteroids; the frequency is unknown.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

4.9

Overdose
Excess use of topical corticosteroids may produce systemic adverse effects.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pramocaine hydrochloride is a surface anaesthetic and thus relieves the pain of
anal and perianal conditions.
The use of steroids in inflammatory conditions is well known.

5.2

Pharmacokinetic properties
Not applicable.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Cetyl alcohol
Emulsifying wax
Methyl parahydroxybenzoate
Polyoxyethylene (10), stearyl ether
Propylene glycol
Propyl parahydroxybenzoate
Triethanolamine
Purified water
Propellant HP-70 Consisting of:
- Isobutane
- Propane

6.2

Incompatibilities
Compatibility with barrier methods of contraception has not been
demonstrated.

6.3

Shelf life
30 months.

6.4

Special precautions for storage
Pressurised container containing flammable propellant. Protect from sunlight. Do
not expose to temperatures above 50oC. Do not spray on a naked flame or any
incandescent material. Keep away from sources of ignition - no smoking. Do not
pierce or burn, even after use.
Do not refrigerate. Store below 25oC

6.5

Nature and contents of container
Aerosol canister containing 20 g of product plus 1.2 g of inert propellant. A 10%
overage of product and propellant is included to ensure the required number of doses
can be achieved.

6.6

Special precautions for disposal
1.
Shake the canister vigorously for 30 seconds before each use.
For internal use
2.
3.

4.
5.
6.
7.

Withdraw the plunger slowly until it stops at the catch line.
Holding UPRIGHT, insert the canister top into the applicator tip. Make
sure you hold the plunger and applicator body FIRMLY with your
fingers.
Fill applicator so that the foam fills about ¼ of the applicator body. Only
a short press is needed to do this.
Wait until foam has stopped expanding.
Repeat steps 4 & 5 until the foam expands to just reach the “Fill” line.
This normally takes 2 - 4 short press/waits.
Stand with one leg raised on a chair, or lie down on your side. Insert
gently into the back passage and push the plunger fully into the
applicator.

For external use
8.

Expel a small quantity of foam onto a tissue, pad or two fingers and
apply the foam to the affected area.

These instructions are provided on the leaflet with illustrations to assist
understanding.
Any unused product or waste material should be disposed of in accordance
with local requirements.

7. MARKETING AUTHORISATION HOLDER
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road

Takeley
Bishop’s Stortford
CM22 6PU

8

MARKETING AUTHORISATION NUMBER(S)
PL 15142/0089

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30/06/2007

10

DATE OF REVISION OF THE TEXT
26/02/2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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